MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137); Halo (2227)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.All product and batch history records are quality reviewed prior to product release.Customer indicated the use of an unknown cartridge.Without the cartridge model number it cannot be determined if this was a qualified product.A handpiece and viscoelastic were provided that are qualified with a qualified cartridge.Root cause: the product investigation could not identify a root cause for the reported complaint.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported a patient experiencing halos following an intraocular lens (iol) implant procedure.The patient was very happy during the first five weeks of having the implant.It was only after being dilated on the 5th week that the patient began reporting halos and blurry vision.Post op vision was 20/20 and patient happy post operatively (prior to dilation at follow up).The iol was exchanged for another model 13 months following the initial implant procedure.The patient also experienced headaches and unable to read prior to the lens exchange.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11465791
• Report Number: 1119421-2021-00535
• Device Sequence Number: 11809593
• Product Code: MFK
• UDI-Device Identifier: 00380652415576
• UDI-Public: 00380652415576
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30U225
• Device Lot Number: 12682061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR